Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
White House: Great Progress in Health Care Coverage, but More Work to Be Done
The White House recently provided on update on agencies’ progress in carrying out EO to boost Medicaid and the Affordable Care Act
Biomarkers Found in Breast Milk Could Lead to Better Cancer Screening
Researchers from Clarkson University and the University of Massachusetts Amherst have discovered breast cancer biomarkers in breast milk that could eventually lead to a blood test for better screening for the disease in all risk and age groups, as the biomarkers...
Device Makers to FDA: Give Us More Time for ISO 13485 Harmonization
On Feb. 23, the U.S. Food and Drug Administration (FDA) issued a proposed rule to harmonize its good manufacturing practices (CGMP) regulations for medical devices with International Standardization Organization (ISO) 13485. The basic proposal is to replace the...
The Craze Is Over but Healthcare SPAC Deals Remain Alive and Well
A hot trend in capital raising for the healthcare and life sciences industries only two years ago, SPAC deals have petered out, but are far from dead.
Join Us April 27th to Discuss How We Can Improve Our Content
Webinar will give you the chance to learn about recent changes at G2 and ask the editorial team any questions you may have.
Congress Strikes Deal on COVID-19 Response Funding
The good news: Congressional negotiators have cut a deal for $10 billion in additional funding for COVID-19 testing and vaccination in the US. The bipartisan package will enable the federal government to purchase more therapeutics, tests, vaccines, and other...
Castle Biosciences Set to Acquire AltheaDx
In a key deal announced this week, Castle Biosciences signed a definitive agreement to acquire commercial-stage molecular diagnostics company AltheaDx, which specializes in pharmacogenomics testing services focused on mental health. In a statement released April 4,...
Medicare Patients Can Now Get Free OTC COVID-19 Tests
Medicare patients can now get over-the-counter (OTC) COVID-19 tests free of charge, CMS announced on Monday. From now through the end of the public health emergency, individuals with Medicare Part B coverage, including those in Medicare Advantage plans, can get up...
Labs in Court Weekly Roundup
Of the enforcement actions announced last week involving laboratories and the health care industry, the majority of cases involved urine drug testing. More specifically, three cases relating to urine drug testing involved an illegal kickback scheme as well as...
Explanatory AI Benefits Doctors Diagnosing Fetal Heart Disease
Researchers from the RIKEN Center for Advanced Intelligence Project (AIP) and colleagues have tested AI-enhanced diagnosis of fetal congenital heart disease in a clinical setting. Both hospital residents and fellows made more accurate diagnoses when they used a...
